Lower riskMedical device recall · FDA · Published March 8, 2022
Abbott ARCHITECT STAT Myoglobin Calibrators Recall: Calibration Errors Risk
Abbott recalls ARCHITECT STAT Myoglobin Calibrators (RES 2K4:01) due to potential calibration errors. Controls may exceed specified ranges if used with this lot, affecting test accuracy.
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Take action
Contact the company
📍Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502
“Abbott ARCHITECT STAT Myoglobin Calibrators Recall: Calibration Errors Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60975-abbott-architect-stat-myoglobin-calibrators-recall-calibration-errors-risk. Based on FDA recall #Z-0891-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0891-2022%22&limit=1).
The FDA announced on March 8, 2022, that Abbott Laboratories is recalling ARCHITECT STAT Myoglobin Calibrators because the lot failed stability testing. This defect may cause control values to exceed specified ranges during use.
How to tell if you have it
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
UPC 00380740003272
The hazard
The calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Context
GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Recent brand recalls include a November 13, 2025 correction for the Alinity ci-series System Control Module and a September 18, 2025 software issue for the Abbott Alinity hq Analyzer. Other recent recalls of similar products include Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
Check for the model RES 2K43-01 on the calibrator. The recall applies to products sold with the UDI (Unique Device Identification) code (01)00380740003272(17)220531(10)166000.
Brand
Abbott
Product
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Results
Review test results to ensure they fall within the specified range as per the Instructions for Use.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0891-2022 (March 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0891-2022 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.