ACL TOP Family 50 Series Models as follows: In vitro… recallZ-2578-2023 · Instrumentation Laboratory · initiated Jul 13, 2023

Why it was recalled

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

FDA root cause category: Under Investigation by firm

What the company is doing

UPDATE: 10/16/23: Update relates to additional ACL TOP Family 50 Series instruments that were installed after the field notification was initiated (Phase I), but prior to inclusion of the notification instructions in start-up kits with new production. During the Installation process, Service field representatives will provide the titled Important Instruction, to the customer. The letter states the same instructions as provided in the Urgent Medical Device Correction Letter initially issued. __________________________________________________________________________ Werfen Issued Urgent Medical Device Correction Letter and Mandatory response tracking form on July 13th, 2023 via email or Certified Mail. Letter states reason for recall, health risk and action to take: Based on the above please take one of the following immediate workflows to mitigate this issue. To avoid the potential sample misidentification, users should not change any samples in the sample rack that have been properly identified. If the user decides they must remove a sample from a sample rack that has been properly identified by the ACL TOP Family 50 Series Instrument, they may do so only after the bar code reader has returned to the home position or the samples have been completely resulted. Alternatively, a user may remove a properly identified sample from a sample rack and must leave that sample rack position empty. x Share this information with your laboratory staff and update your internal procedures, as needed. x Forward this notification to all affected locations in your facility. x Post this notification on all affected systems in your facility. x Retain a copy of this notification for your records. x Complete and return the Mandatory Response Tracking Form to acknowledge the above actions. x Mandatory Response Tracking Record x Return the completed and signed Mandatory Response Tracking Form to: x Fax No.: 1-781-861-4207 Or E-mail: [email protected] x Contact Information for

Recall details

Recall number

Z-2578-2023

Status

Open, Classified

Initiated by the company

Jul 13, 2023

Posted by the FDA

Sep 12, 2023

Recalling firm

Instrumentation Laboratory

Quantity

2,068 kits US: 6,270 units OUS

Product code

GKP

FDA submissions

K150877

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.

Product description

ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• ACL TOP 550 CTS 00000280045

  Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED
  2 recalls3 reports
• ACL TOP 350 CTS 00000280065

  Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED
  2 recalls1 report
• ACL TOP 970 CL 00000280097

  Instrumentation Laboratory Company · System, Multipurpose For In Vitro Coagulation Studies
  2 recalls0 reports
• ACL TOP 750 LAS 00000280035

  Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED
  1 recall4 reports
• ACL TOP 750 CTS 00000280055

  Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED
  1 recall3 reports
• ACL TOP 750 00000280015

  Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED
  1 recall0 reports