ADVIA Chemistry A1c_3 Calibrators — Class II medical device recall Z-2135-2013
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-09-11, distributed nationwide. Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for pat
| Recall number | Z-2135-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BG, BR, CA, CH, CL, CN, CZ, DE, DK, EE, ES, FI, FR, GB, GR, GT, HR, HU, ID, IT, KR, LT, NO, PL, PT, RO, RS, SE, SG, SI, SK, TH, TR, UY, VN, ZA |
| Lot numbers | 1MD014 |
| Model numbers | 10491408 |
| Expiration dates | 2013-05-01, 2014-10-01 |
Product
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.
Reason for recall
Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ¿ 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
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-2135-2013. 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.