Recall Z-2854-2026 ยท JQP Calculator/Data Processing Module, For Clinical Use
Copan WASP
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user inte
| Date | Jul 31, 2026 (initiated Jun 16, 2026) |
| Status | Open, Classified |
| Reason | Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. |
| Root cause | Under Investigation by firm |
| Action | On 06/16/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was provided to customers informing them that, A software bug has been identified in the WebApp software which, under specific conditions, may prevent the result suggested by PhenoMATRIX from being overwritten by the result selected by the user. As a consequence, the result transmitted by WASPLab to the LIS may be the result suggested by PhenoMATRIX, rather than the result selected by the user. Customers were informed and instructed: In date 2026/06/15 we released a WebApp software version including the bugfix of this issue. As a consequ |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.