Z-1135-2021Class III

S-O303000 Control, Stat-Site B-Hb, 2X3ml,1low,1high -

Name: Z-1135-2021 S-O303000 Control, Stat-Site B-Hb, 2X3ml,1low,1high -
Creator: Medline Industries Inc
Published: 2021-01-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-01-15 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum... on 2021-01-15. FDA classified it as Class III and gives the reason as "Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1135-2021
Classification: Class III
Status: Terminated
Initiated: 2021-01-15
Posted: 2021-02-19
Terminated: 2023-01-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline sent an "URGENT RECALL NOTIFICATION" on 01/15/2021 to customers, requesting: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704.
Quantity in commerce: 46 units
Distribution: US Nationwide distribution in the states of MS, OH, IL.
Product codes and lots: Model Number: S-O303000; Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831; Lot Number and/or Serial Number: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1135-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1135-2021	Class III	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)