Health product recall

Diamed ID-Systems

Brand(s)
Last updated

Summary

Product
Diamed ID-Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Coombs Anti-IgG

More than 10 numbers, contact manufacturer.

004024
004026
004027

ID-DiaCell I-II-III

More than 10 numbers, contact manufacturer.

004310

LISS/Coombs

More than 10 numbers, contact manufacturer.

004014
004017

Issue

An increased level of complaints and adverse events related to weak non-specific reactions when using ID-system screening reagents in Indirect Antiglobulin Testing (IAT) for qc, donor, and patient samples. Customers using both, the manual and instrument methods reported weak positive reaction results (identified as "?", "wr", "+/-", and sometimes "+" on instruments) instead of an expected clearly negative "-" reaction in IAT. These doubtful reactions or in some cases weak positive reactions may occur randomly among batches. The investigations so far point out that a possible enhancer of the phenomenon is the combination of certain lots of reagents red blood cells with certain lots of associated ID-cards.

Recall start date: March 11, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Diamed GmbH

Pra Rond 23, Cressier Fr, Switzerland, 1785

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75284

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