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ACL ELITE Coagulation Analyzer, PN 00000880311 recallZ-0806-2011 · Instrumentation Laboratory Co. · initiated Nov 11, 2010

Terminated All recalls posted in December 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Instrumentation Laboratory Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sporadically lowered APTT results were observed with the PT/APTT Test Groups.

FDA root cause category: Device Design

What the company is doing

On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.

Recall details

Recall number
Z-0806-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 11, 2010
Posted by the FDA
Dec 27, 2010
Recalling firm
Instrumentation Laboratory Co.
Quantity
514 distributed in USA & Canada, 55 in distribution channel subject to recall
Product code
JPA
FDA submissions
K060162
Distribution
Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK.

Product description

ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.

Code information (models, lots, serial numbers)

Serial numbers range 05010100 - 10111176.

Other devices under the same FDA submission

4 devices cleared under K060162 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 57274).

Sources and updates

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