Summary
- Company Announcement Date:
- August 28, 2023
- FDA Publish Date:
- August 31, 2023
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason Description
Due to lack of appropriate premarket clearance or approval which potentially could result in inaccurate test results
- Company Name:
- Universal Meditech Inc.
- Brand Name:
-
Brand Name(s)
Healthy Wiser and more
- Product Description:
-
Product Description
Company Announcement
On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that:
- The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products.
- Three of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips and HealthyWiser KetoFast™ Ketone Test Strips) has been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.
Consumers who still have unused tests manufactured by Universal Meditech Inc. (please refer to product identifications below) should stop using the device immediately and:
- discard any remaining stock in the trash
- or ship back to Universal Meditech at our expense (please contact us for the courier account information).
Recalled products were manufactured and distributed from March 2021 to November 2022.
The following styles/models/UDI have been recalled:
|
No. |
Product Name |
UDI Number |
Lot Number to be Recalled |
|---|---|---|---|
| 1 | One Step® Pregnancy Test | B512100011 | 3-H25052-20UMI |
| 3-H07102-20UMI | |||
| 2 | One Step® Ovulation Test* | B512200011 | 3-L12121-20UMI |
| 3-L07102-20UMI | |||
| 3 | HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis | None** | URS-1-2104-01 |
| URS-1-2102-02 | |||
| URS-1-2105-01 | |||
| URS-1-2106-02 | |||
| URS-1-2110-02 | |||
| 4 | HealthyWiser UriTest™ UTI Test Strips | None** | URS-1-2102-03 |
| URS-1-2106-01 | |||
| URS-1-2202-01-Q | |||
| URS-1-2204-01 | |||
| URS-1-2207-01 | |||
| URS-1-2209-01 | |||
| 5 | HealthyWiser KetoFast™ Ketone Test Strips | None** | URS-1-2104-02 |
| 6 | HealthyWiser pH-Aware™ pH Test Strips | None** | URS-1-2105-01-Q |
| URS-1-2105-02-Q | |||
| URS-1-2108-01-Q | |||
| URS-1-2109-01-Q | |||
| URS-1-2111-01-Q | |||
| 7 | hCG Pregnancy Cassette | None** | hCG-M5-2101-01 |
| hCG-M5-2104-01 | |||
| hCG-M5-2106-01 | |||
| hCG-M5-2107-01 | |||
| hCG-M5-2108-01 | |||
| hCG-M5-2110-01 | |||
| hCG-M5-2202-01 | |||
| hCG-M5-2202-02 | |||
| hCG-M5-2202-03 | |||
| hCG-M5-2203-01 | |||
| hCG-M5-2204-01 | |||
| hCG-M5-2204-02 | |||
| hCG-M5-2204-03 | |||
| hCG-M5-2206-01 | |||
| hCG-M5-2206-02 | |||
| hCG-M5-2207-01 | |||
| hCG-M5-2210-02 | |||
| 8 | Am I Pregnant Pregnancy Midstream Test | None** | hCG-MHM-2205-01 |
| hCG-MHM-2207-01 | |||
| hCG-MHM-2207-02 | |||
| hCG-MHM-2207-03 | |||
| hCG-MHM-2207-04 | |||
| hCG-MHM-2208-01 | |||
| hCG-MHM-2209-01 | |||
| hCG-MHM-2209-02 | |||
| hCG-MHM-2209-03 | |||
| HCG-MHM-2210-01 | |||
| HCG-MHM-2210-02 | |||
| 9 | hCG Pregnancy Strips | None** | hCG-S-2210-03 |
| 10 | PrestiBio™ Breastmilk Alcohol Test Strip | None** | Any Lot Number |
| 11 | PrestiBio™ Ovulation Strips*** | None** | Any Lot Number |
| 12 | PrestiBio™ Ovulation and Pregnancy Strips | None** | Any Lot Number |
| 13 | PrestiBio™ Pregnancy Strips**** | None** | Any Lot Number |
| 14 | PrestiBio™ Rapid Detection Pregnancy Test Midstream | None** | Any Lot Number |
| 15 | PrestiBio™ Ketone Test Strips | None** | Any Lot Number |
| 16 | PrestiBio™ Urinalysis Test Strip | None** | Any Lot Number |
*Note: This product is exempted from 510(k), so that it was legally distributed without it having been reviewed or cleared by the FDA. However, an “FDA Cleared” verbiage was printed on the product labeling, which was misleading and violative.
**Note: FDA has mandated these products to bear a Unique Device Identifier (UDI) on their labeling, but Universal Meditech has failed to comply with this requirement.
***Note: This is the brand name that appears on the outer box of the product. The name that appears on the pouches inside the box is PrestiBio LH TEST STRIP Urine Test Strip.
****Note: This is the brand name that appears on the outer box of the product. The name that appears on the pouches inside the box is PrestiBio HCG TEST STRIP Urine Test Strip.
Products were distributed with packaging boxes identified below:
To date, there has not been any reported injury due to the use of any of the products.
Universal Meditech Inc. is notifying its distributors by email and is arranging for the return of all recalled products.
Universal Meditech Inc. has distributed the products to distributors in California, New York, New Jersey, and Florida, and these products may have been further sold to end consumers national-wide across the United States.
Consumers with questions may contact the legal attorney of the company via telephone at +1(702)871-9888 between the hours of 9AM and 5PM, P.S.T. Consumer may also contact the legal attorney of the company via e-mail at [email protected].
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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