ACL ELITE PRO Coagulation Analyzer, PN 00001000311 recallZ-0807-2011 · Instrumentation Laboratory Co. · initiated Nov 11, 2010
Terminated All recalls posted in December 2010
Is my device affected?
- 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.
- 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.
- 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-0807-2011
- 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
- 379 in use in USA & Canada, 24 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 PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
Code information (models, lots, serial numbers)
Serial numbers range 05010100 - 10111779.
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.
- ACL ELITE PRO 00001000311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 57274).
- Z-0803-2011 · TerminatedACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
- Z-0804-2011 · TerminatedACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.
- Z-0805-2011 · TerminatedACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
- Z-0806-2011 · TerminatedACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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