Z-0605-2018Class II

Lyophilized Chemistry Calibrator Level 1

Name: Z-0605-2018 Lyophilized Chemistry Calibrator Level 1
Creator: Beckman Coulter Inc.
Published: 2017-08-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-08-24 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman... on 2017-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0605-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-24
Posted: 2018-02-13
Terminated: 2020-08-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: Lots # 6101K51 and 6101K61

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0605-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0605-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code JIX

K043460Class IIOlympus Lyophilized Chemistry Calibrators Dr0070 and Dr0071Olympus America, Inc. / cleared 2005-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)