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U.S. Department of Health and Human Services

Class 2 Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2

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  Class 2 Device Recall Lyophilized Chemistry Calibrator Level 1 and Level 2 see related information
Date Initiated by Firm August 24, 2017
Create Date February 13, 2018
Recall Status1 Terminated 3 on August 28, 2020
Recall Number Z-0605-2018
Recall Event ID 78699
510(K)Number K043460  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
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.
Code Information Lots # 6101K51 and 6101K61
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Customer Support
800-854-3633
Manufacturer 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.
FDA Determined
Cause 2		 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 6101K51 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Incorrect pair Calibrator Level 1  REF DR0070-1, Lot 6101K61 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Correct pair IMPACT: ¿ 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. Calibrator Level 1  REF DR0070-1, Lot 6101K51 Calibrator Level 2  REF DR0070-2, Lot 6102K61 Incorrect pair ¿ If the above incorrect pair is run with Level 1 lot 6101K51and Level 2 lot 6102K51 set points, erroneous results could be generated for the following assays: o Bicarbonate : maximum 11% bias low o Calcium Arsenazo : maximum 5% bias low o Calcium oCPC : maximum 5% bias low o Inorganic Phosphorous : 6.4% bias high o Magnesium: 3.2% bias low ¿ If the above incorrect pair is run with Level 1 lot 6101K61 and Level 2 lot 6102K61 set points, erroneous results could be generated for the following assays: o Bicarbonate : maximum 15.8% bias high o Direct Bilirubin OSR6x181: 8.7% bias low ACTION: ¿ Check the level 1 and level 2 calibrators to make sure you are using correctly paired lots for calibration. ¿ Ensure correct set points are being used for the lot. Set points are in the IFU for each lot and can be found in each kit, or on the Beckman Coulter websites
Quantity in Commerce 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, Paraguay, and Peru
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = OLYMPUS AMERICA, INC.
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