Z-1396-2009

Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle...

Name: Z-1396-2009 Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle...
Creator: Beckman Coulter Inc
Published: 2007-09-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-09-27 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative... on 2007-09-27. The reason FDA records is "Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1396-2009
Status: Terminated
Initiated: 2007-09-27
Posted: 2009-05-22
Terminated: 2009-05-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Product code: DDR Myoglobin, Antigen, Antiserum, Control
Reason for recall: Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.
Quantity in commerce: 20,727
Distribution: Nationwide and Canada.
Product codes and lots: All Lot Numbers.

Product code DDR

K021229Class IIMyoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244Beckman Coulter, Inc. / cleared 2002-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)