Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-2066-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: June 13, 2018

Recall Number: Z-2066-2018

Event ID: 79813

Reason for Recall:

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Status: Terminated

Product Quantity: 15942

Code Information:

All Lot Codes

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

Voluntary or Mandated:

Voluntary: Firm initiated