Reported Apr 27, 2022 · Ongoing
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB…
Beckman Coulter, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 11800 Sw 147th Ave · Miami, FL · 33196-2500
Is this the product you have?
- Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
- Lot codes and dates
Lot #583-21 and higherUDI 10837461002611
- Amount recalled
- 12,306 kits
Where it was sold
- Nationwide
- PR
Why it was recalled
IRISpec CA failures for glucose.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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