BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.
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BD Kiestra" ReadA; Catalog No.: 446948.
Hazard / Issue
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
Issued by
FDA
Affected States: KS, MD, MN, NJ, TX, VA
Lot/Code Info: Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for BD Kiestra" ReadA; →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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