Health product recall

Lactate Gen. 2 in CSF and Bilirubin Total Gen 3 (BILT3) (2019-05-14)

Starting date:
May 14, 2019
Posting date:
June 7, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70119

Last updated: 2019-06-07

Affected Products

  1. Lactate Gen. 2 in CSF
  2. Bilirubin Total Gen 3 (BILT3)

Reason

Selected endogenous interferences in serum/plasma, urine and cerebrospinal fluid were assessed and new endogenous interferences claims for Bilirubin Total Gen. 3 and Lactate Gen. 2 used on COBAS INTEGRA 400 plus and COBAS c111 were found.

Affected products

A. Lactate Gen. 2 in CSF

Lot or serial number

33763601
35514701
37432001
37432101
38897701

Model or catalog number

3183700190

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY

B. Bilirubin Total Gen 3 (BILT3)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5795397190
5795648190

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY

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