Synchron Systems Synchron Calibrator Multi Calibrator Diskettes — Class III medical device recall Z-0110-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-31, distributed nationwide. The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Mult
| Recall number | Z-0110-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2011-12-15 |
| Classified | 2012-10-22 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2012-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AU, BD, BE, BG, BR, CA, CH, CN, CO, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, ID, IE, IL, IN, IT, JO, JP, KE, KW, LB, LT, MA, MX, MY, NG, NL, NZ, OM, PA, PH, PK, PL, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, VN, ZA |
| Reason classes | labeling |
| Lot numbers | M002642 |
| Model numbers | 442600 |
Product
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
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-0110-2013. 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.