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MICROSTREP PLUS 1 AND 2 (2015-09-07)
- Starting date:
- September 7, 2015
- Posting date:
- October 5, 2015
- 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-55214
Affected Products
- MICROSTREP PLUS 1
- MICROSTREP PLUS 2
Reason
Beckman Coulter has received reports regarding ampicillin and penicillin false resistance with clinical isolates and out-of-range (high) quality control (QC) results on the MICROSTREP Plus 1 (MSTRP+1) and MICROSTREP Plus 2 (MSTRP+2) panel lots included in this recall. Beckman Coulter investigation has confirmed a manufacturing error leading to antimicrobic degredation and the potential for elevated or false resistant results for some antimicrobics (e.g. ampicillin and penicillin) in a portion of the panels within these lots.
Affected products
A. MICROSTREP PLUS 1
Lot or serial number
- 2016-01-27
- 2016-02-27
- 2016-03-26
- 2016-04-02
- 2016-04-14
- 2016-05-01
- 2016-05-15
- 2016-06-12
Model or catalog number
- B1027-201
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. MICROSTREP PLUS 2
Lot or serial number
- 2016-01-30
- 2016-03-23
Model or catalog number
- B1027-202
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES