Beckman Coulter Chemistry Calibrators: Incorrect Pairing Risk
Beckman Coulter recalls two specific lots of lyophilized chemistry calibrators (6101K51 and 6101K61) that must be used in exact pairs to avoid calibration errors. Using mismatched pairs may cause inaccurate test results.
Lower-risk 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.
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What happened, in plain English
Beckman Coulter is recalling two specific lots of lyophilized chemistry calibrators (6101K51 and 6101K61) that must be used in exact pairs. Using mismatched pairs can cause inaccurate test results, potentially leading to QC failures. Read more at govinfonow.com/recall/73121-beckman-coulter-chemistry-calibrators-incorrect-pairing-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73121-beckman-coulter-chemistry-calibrators-incorrect-pairing-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0605-2018
Cite this page
“Beckman Coulter Chemistry Calibrators: Incorrect Pairing Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73121-beckman-coulter-chemistry-calibrators-incorrect-pairing-risk. Based on FDA recall #Z-0605-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2018%22&limit=1).
Why it’s dangerous
The calibrators must be used in exact pairs (level 1 and level 2 together). If mismatched pairs are used, calibration results may be inaccurate, leading to potential QC failures in clinical testing.
Who’s affected
Users of Beckman Coulter AU series chemistry analyzers who have lots 6101K51 or 6101K61 of the calibrators are affected. Laboratory staff and healthcare professionals using these calibrators for clinical testing are most at risk.
How to tell if you have this one
Check if your Beckman Coulter AU chemistry analyzer uses calibrators with lot numbers 6101K51 or 6101K61. These specific lots were recalled due to pairing requirements.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Verify Lot Numbers
Check the lot numbers on your calibrators to ensure they are 6101K51 or 6101K61.
Where it went and when
Where it was distributed
Distributed in 43 states, and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0605-2018 (August 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0605-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.