Recall Z-1333-2021 ยท KPA Slide Stainer, Automated
Biocare Medical, LLC
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
| Date | Feb 25, 2021 |
| Status | Terminated |
| Reason | Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations. |
| Root cause | Software Design Change |
| Action | On 2/25/2021, BIOCARE Medical emailed and "Medical Device Recall" Notification to all affected consignees. In addition to informing consignees about the recall, the firm requested consignees take the following actions: 1. Do not use the product in the Multi Batching mode. 2. Do not interrupt a run during a Single Batch mode run or access the working deck while the instrument is in operation. 3. Always run positive controls per CAP and CLIA guidance to avoid the potential for false negative result from contaminated reagents. 4. If the malfunction does occur: " Do not open the cover and acces |
| Quantity | 72 units |
| Distribution | US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.