"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0… — Class II medical device recall Z-1688-2020
Terminated recall by Abbott Laboratories, reported 2020-04-15, distributed nationwide. Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer ob
| Recall number | Z-1688-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2019-05-22 |
| Classified | 2020-04-09 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, ES, IT, ZA |
| Quantity | 198 kits |
| Reason classes | potency |
| Lot numbers | 54582UQ02 |
| Model numbers | 307261/R03, 4P52-01, S4P5X0 |
Product
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Reason for recall
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1688-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.