Lower riskMedical device recall · FDA · Published May 7, 2018
Roche Accu-Chek Performa Test Strips: Risk of Glucose Measurement Errors
Roche recalls Accu-Chek Performa test strips that may cause inaccurate blood glucose readings, leading to incorrect health decisions. Affected lots include 476605. Consumers should check their test strip lot numbers.
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
Take action
Contact the company
📍Recalling firmRoche Diabetes Care, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025
“Roche Accu-Chek Performa Test Strips: Risk of Glucose Measurement Errors.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71182-roche-accu-chek-performa-test-strips-risk-of-glucose-measurement. Based on FDA recall #Z-2186-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2186-2018%22&limit=1).
Roche Diabetes Care, Inc. recalled Accu-Chek Performa Test Strips on May 7, 2018, according to the FDA. The agency announced that two lots of test strips are out of specification due to potential strip errors or biased results.
How to tell if you have it
Brand: Roche
Product: Accu-Chek Performa Test Strip
Catalog no.: 07299702001
Lot code: 476605
The hazard
The FDA said the affected test strips show an increased potential for strip errors prior to applying a blood sample, strips not detected once inserted, or a biased result that may not be detectable. A biased result could lead users to take incorrect action in response to the displayed blood glucose result compared to the actual value.
Context
GovInfoNow's records show Roche Diabetes Care, Inc. has had nine other recalls since June 8, 2017. Other recent recalls of similar products include Roche Accu-Chek Guide (SC) Kit (May 13, 2024), Roche Diabetes Care Software Version 2.5.2 (March 9, 2022), and Roche Accu-Chek Inform II Test Strips (July 28, 2021). Other recent recalls of similar products include Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor (Nov. 24, 2025) and Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025).
How to tell if you have this one
Check the lot number on the test strip packaging. The affected lot is 476605. The product is sold under the Accu-Chek Performa brand for blood glucose monitoring.
Brand
Roche
Category
Medical device
FDA recall event · 3 products
All 3 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 II
Status
Terminated
Distribution
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Recall number
Product, codes & lots
Quantity
Z-2185-2018
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.; Lots 496947, 497291, 497296, 497325
295, 248
Z-2186-2018
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.; Lot 476605
295,248
Z-2187-2018
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.; Lot 476340
295,248
Based on the official FDA remedy
What to do — step by step
Check Test Strip Lot Number
Look for the lot number on the test strip packaging to see if it matches the affected lot 476605.
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 distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic…” 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 terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2186-2018 (May 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2186-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.