Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published September 11, 2019

Roche cobas Integra Albumin Gen.2 test kit recall: Low quality control risk

Roche recalls specific albumin test kits due to potential quality control issues affecting accuracy. Affected lots include 33962301 and 37437: 12/20/19 expansion.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0152-2020Medical deviceRoche ›
Take action

Contact the company

Recalling firmRoche Diagnostics Operations, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025
✎ GovInfoNow plain-language explainer

Roche is recalling certain albumin test kits that may have quality control issues, which could lead to inaccurate results. This affects users who rely on these tests for medical diagnosis. Read more at govinfonow.com/recall/67036-roche-cobas-integra-albumin-gen-2-test-kit-recall-low.

Source Summary by GovInfoNow · govinfonow.com/recall/67036-roche-cobas-integra-albumin-gen-2-test-kit-recall-low · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0152-2020

Cite this page

“Roche cobas Integra Albumin Gen.2 test kit recall: Low quality control risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67036-roche-cobas-integra-albumin-gen-2-test-kit-recall-low. Based on FDA recall #Z-0152-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0152-2020%22&limit=1).

The FDA announced on Sept. 11, 2019, that Roche Diagnostics Operations, Inc. voluntarily recalled its cobas Integra Albumin Gen.2 in vitro test due to low quality control recovery and invalid calibration. The recall affects lots distributed nationwide.

How to tell if you have it

  • Brand: Roche
  • Product: Roche Diagnostics cobas Integra Albumin Gen.2
  • Catalog Number: 05166861190
  • Lot #33962301
  • Lot #37437301 (added Dec. 20, 2019)

The hazard

The recall was issued because of low Quality Control recovery and invalid Calibration in the Roche Diagnostics cobas Integra Albumin Gen.2 test. The product is an in vitro test for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Context

GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls since July 2, 2019. Other recent recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (July 6, 2026), the Siemens Atellica CH Urine Albumin Recall (Jan. 20, 2026), and the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025).

How to tell if you have this one

Check for catalog number 05166861190 on the test kit. The affected lots are 33962301 and 37437301, expanded to include these lots on December 20, 2019.

  • Brand
    Roche
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
Recall numberProduct, codes & lotsQuantity
Z-0152-2020Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.; Lot # 33962301. Expanded on 12/20/19 to include lot 374373017,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Z-0153-2020Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.; Lot # 361338012,304 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Verify the catalog number and lot number on the test kit to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 31 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 4.8 years after the firm started it.

1. Firm started the recall: Sep 11, 201912. FDA classified it Class III: Oct 16, 201923. Published in FDA’s Enforcement Report: Oct 23, 201934. FDA terminated the recall: Jun 11, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the test kit?

No specific stop-use instruction is provided; check the kit details to confirm if it is affected.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0152-2020 (September 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0152-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA