Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman… — Class II medical device recall Z-0605-2018
Terminated recall by Beckman Coulter Inc., reported 2018-02-21, distributed in AK, AL, AZ, CA, CO, CT, DE, FL…. Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 a
| Recall number | Z-0605-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-08-24 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2020-08-28 |
| Distributed | AK, AL, AZ, CA, CO, CT, DE, FL, GA, GU, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WI, WV, WY |
| Countries outside the US | BR, CA, CR, PE, PY, SV |
| Lot numbers | 6101K51, 6101K61 |
Product
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.
Reason for recall
Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators 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-0605-2018. 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.