Z-0057-2024Class II

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

Name: Z-0057-2024 PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Creator: Universal Meditech Inc.
Published: 2023-05-22
License: https://open.fda.gov/license/

Universal Meditech Inc. / initiated 2023-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Universal Meditech Inc. began a recall of PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 on 2023-05-22. FDA classified it as Class II and gives the reason as "Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0057-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-22
Posted: 2023-10-23
Recalling firm: Universal Meditech Inc.
Product: PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Product code: JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Reason for recall: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email [email protected] Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Quantity in commerce: Unknown
Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
Product codes and lots: Model Number: 900-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0057-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0042-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0043-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0044-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0045-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0046-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0047-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0048-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0049-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0050-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0051-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0052-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0053-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0054-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0055-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0056-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0057-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0058-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0059-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0060-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0061-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0062-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0063-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0064-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0065-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0066-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0067-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0068-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23

Product code JMT

K993850Class IUrinalysis Reagent Strips (10 Parameters)International Newtech Development, Inc. / cleared 2000-01-03

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)