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Synchron Systems Reagents (2013-11-15)
- Starting date:
- November 15, 2013
- Posting date:
- January 6, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37273
Recalled products
- Synchron System Phosphorous Reagent (PHOS)
- Synchron System Total Bilirubin Reagent (TBIL)
- Synchron Systems Uric Acid Reagent (URIC)
- Synchron Systems Triglycerides (TG) Reagent
- Synchron CX Systems Salicylate Reagent
- Synchron Systems Iron (FE) Reagent
- Synchron System Phosphorous Reagent (PHOS)
- Synchron Systems Enzymatic Creatinine (CR-E) Reag
- Synchron Systems G7 Amylase (AMY7) Reagent
- Synchron Systems Lactate Reagent
Reason
Beckman Coulter has reassessed the claims of the observed effect of lipemia, icterus, and hemolysis.
Affected products
A. Synchron System Phosphorous Reagent (PHOS)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- A09426
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Synchron System Total Bilirubin Reagent (TBIL)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 442745
- 476861
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Synchron Systems Uric Acid Reagent (URIC)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 442785
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. Synchron Systems Triglycerides (TG) Reagent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 445850
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. Synchron CX Systems Salicylate Reagent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 378194
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
F. Synchron Systems Iron (FE) Reagent
Lot or serial number
- M010639
- M012288
- M103447
- M105337
- M107382
- M108315
- M202354
- M205271
- M208162
- M209253
Model or catalog number
- 467910
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
G. Synchron System Phosphorous Reagent (PHOS)
Lot or serial number
- M103448
- M206226
Model or catalog number
- 465970
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
H. Synchron Systems Enzymatic Creatinine (CR-E) Reagent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- A60298
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
I. Synchron Systems G7 Amylase (AMY7) Reagent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- A71607
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
J. Synchron Systems Lactate Reagent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- A95550
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES