Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Produc

FDA device recall Z-1491-2026 · posted 2026-03-03 · Open, Classified

Recall details

Recalling firm

Diagnostica Stago, Inc.

Reason for recall

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

Action taken

On February 4, 2026 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions required: If you currently have one or more kits of STA LIATEST FREE PROTEIN S 6 : - For REF 00516: Lots 271971, 272859, and 273018 with a short expiration date we ask you to discontinue their use and dispose of them in accordance with your local regulations. Stago will provide a credit for any destroyed kits. - For REF 00516: lot 273426: o If the initial barcode sheet provided with the kit has already been loaded into the instrument: - Stop the use the initial barcode pre-calibration settings. - Replace the initial barcode settings with the new pre-calibration barcode settings attached, by following to the procedure described in Appendix 1 of this letter. o If the initial barcode sheet has not yet been loaded into the instrument: - Do not use it and proceed to load the lot using the new pre-calibration barcodes provided in the attachment.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GGP

Quantity affected

369

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUS

Date initiated

2026-02-04

Date posted

2026-03-03

Location

Parsippany, NJ

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