Recall Z-0605-2018 ยท JIX Calibrator, Multi-Analyte Mixture
Beckman Coulter Inc.
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. Th
| Date | Aug 24, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On August 28, 2017 a letter was sent to all the customers stating the following: Attention Beckman Coulter Customer, Beckman Coulter is initiating a field action for the product listed above. This letter contains important information that needs your immediate attention. ISSUE: 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. Paired calibrator lots are identified by the last two digits of the lot number. Calibrator Level 1 REF DR0070-1, Lot |
| Quantity | unknown |
| Distribution | Worldwide Distribution in the states of AL, AK, AZ, AK, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IO, KS, KY, LA, MA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WV, WI, and WY and the countries of Brazil, Canada, Costa Rica, El Salvador, Guam, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043460 | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 Olympus America, Inc., Jan 31, 2005 |