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D-10 220-0112

by Bio-Rad Laboratories

D-10 220-0112 (2200112) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K041444 on 9 Jun 2004 (1 earlier submission) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817003301), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847817003301 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041444 Date9 Jun 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041444 decided 9 Jun 2004 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00847817003301 listed 12 Sep 2016 Listed

Recalls

8 recalls · FDA

    • Terminated Z-1299-2014 FDA Class II initiated 27 Feb 2014

    On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

    • Terminated Z-0965-2014 FDA Class III initiated 22 Nov 2013

    D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.

  • 3 recalls, same reason

    • Terminated Z-0018-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011
    • Terminated Z-0017-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011
    • Terminated Z-0019-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011

    A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.

    • Terminated Z-2889-2011 FDA Unclassified (pre-2012) initiated 11 Jul 2011

    Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.

    • Terminated Z-1969-2011 FDA Unclassified (pre-2012) initiated 8 Sep 2010

    The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.

    • Terminated Z-0376-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006 on shared 510(k) K041444

    The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

11 dated events

  1. Cleared FDA 510(k) K041444
  2. Recall initiated FDA recalls Z-0376-2007
  3. Recall initiated FDA recalls Z-1969-2011
  4. Recall initiated FDA recalls Z-2889-2011
  5. Recall initiated FDA recalls Z-0018-2012
  6. Recall initiated FDA recalls Z-0017-2012
  7. Recall initiated FDA recalls Z-0019-2012
  8. Recall initiated FDA recalls Z-0965-2014
  9. Recall initiated FDA recalls Z-1299-2014
  10. Listed FDA GUDID 00847817003301

1 earlier event are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
D-10
Generic name
Haemoglobin A2 (HbA2) IVD, reagent
Model / Ref / Catalog
220-0112, 2200112
Primary DI / UDI-DI
00847817003301
510(k) Number
FDA product code
LCP, JPD
GMDN term
Haemoglobin A2 (HbA2) IVD, reagent
Device class
Class II
Regulation number
864.7470, 864.7400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagentHaemoglobin A2 (HbA2) IVD, reagent

Cleared under the same submission (K031043)

and 3 more cleared under K031043

Cleared under the same submission (K041444)

and 5 more cleared under K041444

Similar devices

Also classified as Haemoglobin A2 (HbA2) IVD, reagent.

Similar devices

Other devices filed under FDA product code LCP (ASSAY, GLYCOSYLATED HEMOGLOBIN).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)