Z-2200-2019Class II

HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only...

Name: Z-2200-2019 HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only...
Creator: Hycor Biomedical Inc
Published: 2018-03-19
License: https://open.fda.gov/license/

Hycor Biomedical / initiated 2018-03-19 / Open, Classified / root cause: labeling and UDI

FDA source

Hycor Biomedical Inc began a recall of HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF... on 2018-03-19. FDA classified it as Class II and gives the reason as "Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2200-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-03-19
Posted: 2019-08-06
Recalling firm: Hycor Biomedical
Product: HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On March 19, 2018, Hycor Biomedical sent a "Urgent Field Safety Notice" via Federal Express to consignees. The urgent field safety notices recommending the following steps to detect and minimize possible sample carryover: 1. Repeat testing of all patient samples for the HYTEC AUTOSTAT II RF assays when the negative control reports out of range. 2. Do not perform HYTEC AUTOSTAT II RF assays in batch mode. HYTEC AUTOSTAT II RF should be tested independently of all other autoimmune assays. 3. Performing testing in duplicate may assist in detecting potential carryover of high levels of IgG from one sample into another reaction well. If the duplicate results do not match, sample carryover may be the root cause. 4. The needle tip of the single tip arm should be cleaned weekly, according to the recommended maintenance schedule. The needle tip should be inspected for damage; a damaged needle tip should be replaced by trained service personnel. 5. It is mandatory that all consignees complete and return the enclosed response within 10 days of receipt, in order for us to verify your understanding of this Field Safety Notice. If you have any questions, please contact Hycor Biomedical at 714-933-3000
Quantity in commerce: 288
Distribution: Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India
Product codes and lots: All lots of RF assay

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2200-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2200-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code DHR

K994338Class IIAutostat II Rheumatoid Factor Igm ElisaCogent Diagnotics , Ltd. / cleared 2000-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)