Aia-Pack B12 Assay

• • Terminated Z-0745-2020 FDA Class III ·initiated 15 Nov 2019

  The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle. In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.

• • Terminated Z-0671-2019 FDA Class II ·initiated 30 Nov 2018

  Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

510(k) Number

K964348 ↗

FDA Product Code

CDD

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Aia-Pack Hgh

  Class I

  FDA 510(k) K905757 Active Cleared 25 Jan 1991

• Aia-Pack Bmg

  Class II

  FDA 510(k) K900440 Active Cleared 26 Feb 1990

• St Aia-Pack Ca 125 Enzyme Immunoassay

  Class II

  FDA 510(k) K023891 Active Cleared 6 Dec 2002

• Aia-Pack Pap Calibration Verification Test Set

  Class I

  FDA 510(k) K924854 Active Cleared 16 Nov 1992

• Aia-Pack Ctni 2ND-Gen Assay

  Class II

  FDA 510(k) K012820 Active Cleared 14 Dec 2001

• Aia-Pack(R) Prog Assay

  Class I

  FDA 510(k) K933269 Active Cleared 22 Oct 1993

See all devices from Tosoh Medics, Inc. →