ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulatio

FDA device recall Z-2578-2023 · posted 2023-09-12 · Open, Classified

Recall details

Recalling firm

Instrumentation Laboratory

Reason for recall

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

Action taken

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: ra-usa.na@werfen.com x Contact Information for

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GKP

Quantity affected

2,068 kits US: 6,270 units OUS

Distribution

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

Date initiated

2023-07-13

Date posted

2023-09-12

Location

Bedford, MA

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