Abbott Laboratories — Class II medical device recall Z-0698-2013
Terminated recall by Abbott Laboratories, reported 2013-01-30, distributed nationwide. The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed result
| Recall number | Z-0698-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2012-12-12 |
| Classified | 2013-01-23 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BB, BE, CA, CH, CN, CO, CY, CZ, DE, DK, ES, FR, GB, GR, HU, IE, IN, IT, JP, LV, MY, NL, NZ, PL, PT, RS, RU, SA, SE, SK, TR |
| Quantity | 28,600 total |
| Reason classes | potency |
| Lot numbers | 00912G000, 01612G000, 02012G000, 02412C000, 02512C000, 02512I000, 02612I000, 03512I000, 03712I000, 19320P100, 19322P100, 19324P100, 19340P100, 19341P100, 19344P100, 19373P100, 19374P100, 19375P100, 19379P100, 19404P100, 19407P100, 19408P100, 19497P100, 20026P100 |
| Expiration dates | 2012-12-26, 2013-07-10, 2013-07-16, 2013-07-17, 2013-10-08, 2013-10-10 |
Product
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
Reason for recall
The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
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-0698-2013. 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.