FDA Device recall Z-1333-2021
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version…
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version… by Biocare Medical, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1333-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-25 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biocare Medical |
| Distribution | AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY |
Product
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
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.
Identifiers
| code_info | Affected US Serial Numbers: BCIP01-0021, BCIP01-0033, BCIP01-0090, BCIP01-0106, BCIP01-0112, BCIP01-0148, BCIP01-0151…Affected US Serial Numbers: BCIP01-0021, BCIP01-0033, BCIP01-0090, BCIP01-0106, BCIP01-0112, BCIP01-0148, BCIP01-0151, BCIP01-0187, BCIP01-0189, BCIP01-0198, BCIP01-0201, BCIP01-0216, BCIP01-0221, BCIP01-0249, BCIP01-0262, BCIP01-0265, BCIP01-0266, BCIP01-0268, BCIP01-0279, BCIP01-0285, BCIP01-0307, BCIP01-0314, BCIP01-0319, BCIP01-0328, BCIP01-0341, BCIP01-0346, BCIP01-0354, BCIP01-0386, BCIP01-0387, BCIP01-0388, BCIP01-0390, BCIP01-0395, BCIP01-0396, BCIP01-0413, BCIP01-0426, BCIP01-0430, BCIP01-0431, BCIP01-0432, BCIP01-0434, BCIP01-0443, BCIP01-0450, BCIP01-0463, BCIP01-0464, BCIP01-0467, BCIP01-0482, BCIP01-0484, BCIP01-0487, BCIP01-0491, BCIP01-0492, BCIP01-0495, BCIP01-0500, BCIP01-0502, BCIP01-0508, BCIP01-0517, BCIP01-0526, BCIP01-0534, BCIP01-0543, BCIP01-0545, BCIP01-0546, BCIP01-0550, BCIP01-0553, BCIP01-0555, BCIP01-0560, BCIP01-0562, BCIP01-0570, BCIP01-0571, BCIP01-0572, BCIP01-0573 Affected OUS serial numbers: BCIP01-0454, BCIP01-0515, BCIP01-0538, BC |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1333-2021%22
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