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U.S. Department of Health and Human Services

Class 2 Device Recall WASPLab

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 Class 2 Device Recall WASPLabsee related information
Date Initiated by FirmJune 16, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2854-2026
Recall Event ID 99302
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductBrand 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 interface of WASPLab device.
Code Information Lot Code: WebApp version 2.33.1, 2.33.3 and 2.34.2
FEI Number 3009288740
Recalling Firm/
Manufacturer		 Copan WASP
Via Achille Grandi, 32
Brescia Italy
Manufacturer Reason
for Recall		Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 consequence, you are required to schedule with your distributor the software update to correct the issue and, in the meanwhile, to check the results sent to LIS in case you changed the result suggested by PhenoMATRIX. Complete the attached Customer Response Form and return to the Copan WASP Srl contact noted on the form so that Copan WASP Srl may acknowledge your receipt of this notification. For questions or further assistance email regulatory.wasp@copangroup.com
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of Arizona.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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