Variant II beta-thalassemia Short Program Model Numbers 270-2103 — Class II medical device recall Z-1537-2014
Terminated recall by Bio-Rad Laboratories, Inc., reported 2014-05-14, distributed in AL, CA, CT, GA, LA, NC, NJ, NY…. There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and
| Recall number | Z-1537-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Hercules, CA, United States |
| Recall initiated | 2014-04-08 |
| Classified | 2014-05-02 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-05-30 |
| Distributed | AL, CA, CT, GA, LA, NC, NJ, NY, WA |
| Countries outside the US | AU, BR, CA, CN, FR, GB, HK, SG, TH |
| Quantity | 457 kits |
| Lot numbers | 64004750, 64005207, 64005302 |
| Model numbers | 270-2103, 270-2154 |
| Expiration dates | 2015-04, 2015-06, 2015-11 |
Product
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
Reason for recall
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
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-1537-2014. 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.