The Access hLH assay is a paramagnetic particle — Class II medical device recall Z-0572-2013
Terminated recall by Beckman Coulter Inc., reported 2012-12-26, distributed nationwide. Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots
| Recall number | Z-0572-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2014-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CH, CL, CN, CO, CR, CZ, DE, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, IE, IL, IN, IT, JO, JP, KE, KW, LB, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 14,409 |
| Reason classes | specification failure |
| Lot numbers | 008546, 011895, 014099, 022519, 109784, 113689, 118299, 122157, 220438, 916872 |
Product
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
Reason for recall
Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
Machine access
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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.