Recalls / —

—#107395

Product

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

FDA product code

CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K994278

Affected lot / code info

Lot Number: 021281

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc.

Address

250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern

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

Timeline

Recall initiated

2011-06-22

Posted by FDA

2012-03-09

Terminated

2012-03-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #107395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.