ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).

FDA device recall Z-1195-2012 · posted 2012-03-09 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.

Action taken

A recall communication was initiated on 6/15/2011 with Beckman forwarding an "Urgent Product Correction" (PCA) letter to all their customers who purchased the Access Immunoassay Systems Ostase Reagent Kits. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the Access Ostase reagent lot identified on the PCA letter and discard all remaining inventory. As stated in the Instructions for Use for Access Ostase, results should be interpreted in light of the total clinical presentation of the patient. All results generated with reagent lot number 021281 where patient results are higher than expected should be evaluated. The affected lot has been removed from Beckman's inventory, and alternate lots will be provided for all current and future replenishment orders or requests. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions can contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call(800) 854-3633 in the US and Canada.

Root cause

Process design

Status

Terminated

Product code

CIN

Quantity affected

318 units total (44 units in US)

Distribution

Worldwide Distribution -- US, including states of FL, IN, VA, CA, and KY and countries of China, Japan, and Panama.

Date initiated

2011-06-22

Date posted

2012-03-09

Date terminated

2012-03-09

Location

Brea, CA

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