ARCHITECT CA 19-9XR Reagent Kit — Class II medical device recall Z-1904-2012
Terminated recall by Abbott Laboratories, reported 2012-07-04, distributed nationwide. The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls
| Recall number | Z-1904-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2012-05-30 |
| Classified | 2012-06-28 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, LT, LU, LV, MA, MX, MY, NL, NZ, OM, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, UY, VE, VN, ZA |
| Lot numbers | 08849M500, 08851M500, 08852M500, 08853M500, 10040M500, 10122M500 |
| Expiration dates | 2012-10-13, 2012-11-30 |
Product
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
Reason for recall
The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
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-1904-2012. 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.